Blazer® II M0045086TK10Recalls & reported problems
Boston Scientific Corporation · Temperature Ablation Catheter · Class 3
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729333364), received between Aug 9, 2022 and Aug 9, 2022 — classified as 1 malfunction.
3 other recalls cover devices cleared under the same FDA submission (P920047); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON ANALYSIS COMPLETED ON 7JUL2022. A BLAZER II WAS RETURNED WITH NO ALLEGATIONS AGAINST THE DEVICE. HOWEVER, RETURNED DEVICE ANALYSIS FOUND THAT CUTS WERE OBSERVED ON THE DISTAL PART OF THE SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15193873 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P920047. One submission often covers many models, so check the product and lot details in each record.
- Z-0202-2019 · Jun 20, 2018 · Open, ClassifiedBoston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
- Z-0973-2011 · Jul 14, 2009 · TerminatedRF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000
- Z-1617-2008 · Feb 14, 2008 · TerminatedBoston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.